A Cluster Randomized Trial of a Telemedicine-Enabled Integrated Care Model for Stroke Prevention and Management in Rural Elderly Adults in China

Sponsor
Jiangsu Province (Suqian) Hospital
Study ID
NCT07628283
Status
Not Yet Recruiting

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Conditions

  • Brain Ischemia
  • Cardiovascular Diseases
  • Cerebral Hemorrhage
  • Hypertension
  • Stroke
  • Transient Ischemic Attack

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enhanced Usual Stroke Care — BEHAVIORAL
    Rural doctors provide monthly face-to-face care based on national guidelines, including symptom monitoring, blood pressure measurement, medication guidance, and patient education. Referrals to tertiary hospitals are made through conventional channels.
  • Digital Health Platform-Supported Integrated Stroke Management — BEHAVIORAL
    Patient electronic health record management AI-powered clinical decision support for medication adjustment based on Chinese stroke guidelines Weekly remote video consultation with neurologists from tertiary hospitals Automated follow-up and medication adherence reminders Structured education and training for both rural doctors and patients

Study Details

This cluster randomized controlled trial aims to evaluate the effectiveness of a novel telemedicine-enabled integrated care model led by rural doctors in reducing cardiovascular and cerebrovascular events among elderly adults (≥65 years) at high risk of stroke in rural China. A total of 39 village clinics will be randomized to either the intervention group (digital health platform-supported integrated care) or the control group (enhanced usual care). The primary outcome is a composite of cardiovascular death, stroke, and hospitalization for heart failure or acute coronary syndrome at 36 months.

Key Dates

First listed
Jun 5, 2026
Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Jun 30, 2030

Study Design

Enrollment
2,510 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Telemedicine-Enabled Integrated Care Group
    Participants receive care from rural doctors using a dedicated digital health support platform, including monthly monitoring, personalized medication adjustment, remote specialist consultation, and structured patient education.
  • Active Comparator: Enhanced Usual Care Group
    Participants receive enhanced usual care from rural doctors who have received standardized training on stroke prevention and management, without the use of the digital health platform.

Primary Outcome Measure

Composite of Cardiovascular Death, Stroke, and Hospitalization for Heart Failure or Acute Coronary Syndrome at 36 Months [ Time Frame: 36 months ]

Central Contacts

  • Liu Qianghui Director of Suqian Hospital, Jiangsu Provincial People's Hospi
    15951598055
    [email protected]

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